Details for New Drug Application (NDA): 022083

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NDA 022083 describes EXELON, which is a drug marketed by Novartis and Sandoz and is included in three NDAs. It is available from two suppliers. Additional details are available on the EXELON profile page.

The generic ingredient in EXELON is rivastigmine. There are thirty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the rivastigmine profile page.

Summary for 022083

Tradename:	EXELON
Applicant:	Sandoz
Ingredient:	rivastigmine
Patents:	0

Pharmacology for NDA: 022083

Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 022083

Cholinesterase Inhibitors
Neuroprotective Agents

Suppliers and Packaging for NDA: 022083

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083	NDA	Novartis Pharmaceuticals Corporation	0078-0501	0078-0501-15	30 PATCH in 1 CARTON (0078-0501-15) / 24 h in 1 PATCH (0078-0501-61)
EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083	NDA	Novartis Pharmaceuticals Corporation	0078-0502	0078-0502-15	30 PATCH in 1 CARTON (0078-0502-15) / 24 h in 1 PATCH (0078-0502-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	4.6MG/24HR
Approval Date:	Jul 6, 2007	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	9.5MG/24HR
Approval Date:	Jul 6, 2007	TE:	AB	RLD:	Yes

Profile for product number 005

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	13.3MG/24HR
Approval Date:	Aug 31, 2012	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022083

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012	⤷ Sign Up	⤷ Sign Up
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007	⤷ Sign Up	⤷ Sign Up
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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